GLYCERIN SUPPOSITORIES CUVE FOR CHILDREN

Introduction

Package Leaflet: Information for the User

Glycerin Suppositories Cuve Children 1.9 g Suppositories

glycerol

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for this medication exactly as stated in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Glycerin Suppositories Cuve Children are and what they are used for
2. What you need to know before starting to use Glycerin Suppositories Cuve Children
3. How to use Glycerin Suppositories Cuve Children
4. Possible side effects
5. Storage of Glycerin Suppositories Cuve Children
6. Package Contents and Additional Information

1. What Glycerin Suppositories Cuve Children are and what they are used for

Glycerol, the active ingredient in this medication, is a laxative administered rectally. The laxative effect is achieved by glycerol's ability to soften stools, which, along with a mild local irritant action, stimulates intestinal movements.

It is indicated for the local symptomatic relief of transient and occasional constipation in children from 6 to 12 years old.

You should consult a doctor if your condition worsens or does not improve after 7 days.

2. What you need to know before starting to use Glycerin Suppositories Cuve Children

Do not useGlycerin Suppositories Cuve Children

• If you are allergic to glycerol or any of the other components of this medication (listed in section 6).
• If you have any anorectal disease, rectocolitis (a type of chronic intestinal inflammation), or inflamed hemorrhoids.

• If you have cramps, colic, nausea, vomiting, or other signs of appendicitis, intestinal obstruction, acute inflammatory intestinal diseases, or any situation of abdominal pain without knowing the cause.

• In children under 6 years old.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Glycerin Suppositories Cuve Children.

In case of blood in stools, irritation, pain, or if it does not improve, you should interrupt treatment and consult a doctor.

Do not use this medication for more than 7 consecutive days, unless your doctor indicates otherwise.

This medication will only be used under strict medical control in patients with severe diseases, especially cardiovascular ones (related to the heart or blood vessels).

Children

This medication is contraindicated in children under 6 years old.

Other Medications and Glycerin Suppositories Cuve Children

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Using Machines

The use of this medication does not affect your ability to drive and/or use machines.

3. How to Use Glycerin Suppositories Cuve Children

Follow the administration instructions for this medication exactly as stated in this package leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Children from 6 to 12 years old:

1 suppository per day, as needed, or as prescribed by the doctor.

Method of administration:

Open the container and remove the suppository. Insert it into the anus deeply and keep the buttocks together for a while.

Delay evacuation as long as possible so that the medication can take effect.

If you notice resistance during administration, you should interrupt it, as it may be harmful and damaging.

Do not use this medication for more than 7 consecutive days. If symptoms do not improve, you should stop treatment and consult a doctor.

If you use more Glycerin Suppositories Cuve Children than you should

It is unlikely that intoxication will occur due to its use.

The abusive and prolonged use of this medication can lead to an irritable colon syndrome (symptoms or discomfort such as alternating constipation and diarrhea, intestinal spasms, bloating, nausea, and gases).

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to use Glycerin Suppositories Cuve Children

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During the period of use of Glycerin Suppositories Cuve Children as a laxative, the following side effects have been observed, whose frequency could not be established with precision:

itching, pain, and irritation of the anus.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Glycerin Suppositories Cuve Children

Keep this medication out of sight and reach of children.

Store below 25 ºC.

Keep the container in the box to protect it from light.

Do not use this medication after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Glycerin Suppositories Cuve Children

• The active ingredient is glycerol. Each suppository contains 1.9 grams of glycerol.
• The other components (excipients) are: sodium carbonate and stearic acid.

Appearance of the Product and Package Contents

Glycerin Suppositories Cuve Children are transparent, colorless, slightly opaque suppositories with a uniform texture and an oval shape, presented in packages of 4 and 12 suppositories.

Marketing Authorization Holder

Pharmex Pharma S.L.U.

C/ Anabel Segura, 16, Edif. 1 Planta 1 dcha.

28108 Alcobendas – Madrid

Spain

Manufacturer

Pharmex Advanced Laboratories, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba) Spain

Date of the Last Revision of this Package Leaflet:February 2011

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).